The document includes 28 questions and answers which discuss, inter alia, the following:
- Procedures, that may be followed to help ensure that electronic records and electronic signatures meet FDA requirements and that the records and signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper
- The use of risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records that are pertinent to clinical investigations.
The Q&A document aims at encouraging and facilitating the use of electronic records and systems to improve the quality and efficiency of clinical investigations. It is intended for sponsors, clinical investigators, institutional review boards and contract research organisations (CROs).
FDA: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Q&A